Annexes to the annual report of the European Medicines Agency 2018 Annex 1 – Members of the Management Board ............................................................................. 2 Annex 2 - Members of the Committee for Medicinal Products for Human Use .................................... 4 Annex 3 – Members of the Pharmacovigilance Risk Assessment Committee ...................................... 6 Annex 4 – Members of the Committee for Medicinal Products for Veterinary Use ............................... 8 Annex 5 – Members of the Committee on Orphan Medicinal Products ............................................ 10 Annex 6 – Members of the Committee on Herbal Medicinal Products.............................................. 12 Annex 7 – Members of the Committee for Advanced Therapies ..................................................... 14 Annex 8 – Members of the Paediatric Committee ........................................................................ 16 Annex 9 – Working parties and working groups .......................................................................... 18 Annex 10 – CHMP opinions on initial evaluations and extensions of therapeutic indication in 2018 .... 24 Annex 11 – Guidelines and concept papers adopted by CHMP in 2018 ........................................... 25 Annex 12 – CVMP opinions on medicinal products for veterinary use in 2018 .................................. 34 Annex 13 – Guidelines and concept papers adopted by CVMP in 2018............................................ 43 Annex 14 – COMP opinions on designation of orphan medicinal products in 2018 ............................ 48 Annex 15 – HMPC European Union herbal monographs in 2018..................................................... 68 Annex 16 – PDCO opinions and EMEA decisions on paediatric investigation plans and waivers in 2018 ............................................................................................................................................ 70 Annex 17 – Referral procedures overview 2018 – human medicines .............................................112 Annex 18 – Arbitrations and referrals in 2018 – veterinary medicines ...........................................115 Annex 19 – Budget summaries 2017–2018 ...............................................................................116 Annex 20 – European Medicines Agency Establishment Plan ........................................................117 Annex 21 – Access to documents requests in 2018 ....................................................................118 Annex 22 – Publications by Agency staff members and experts in 2018 ........................................121
Transcript
Annexes to the annual report of the European Medicines Agency 2018
Annex 1 – Members of the Management Board ............................................................................. 2
Annex 2 - Members of the Committee for Medicinal Products for Human Use .................................... 4
Annex 3 – Members of the Pharmacovigilance Risk Assessment Committee ...................................... 6
Annex 4 – Members of the Committee for Medicinal Products for Veterinary Use ............................... 8
Annex 5 – Members of the Committee on Orphan Medicinal Products ............................................ 10
Annex 6 – Members of the Committee on Herbal Medicinal Products .............................................. 12
Annex 7 – Members of the Committee for Advanced Therapies ..................................................... 14
Annex 8 – Members of the Paediatric Committee ........................................................................ 16
Annex 9 – Working parties and working groups .......................................................................... 18
Annex 10 – CHMP opinions on initial evaluations and extensions of therapeutic indication in 2018 .... 24
Annex 11 – Guidelines and concept papers adopted by CHMP in 2018 ........................................... 25
Annex 12 – CVMP opinions on medicinal products for veterinary use in 2018 .................................. 34
Annex 13 – Guidelines and concept papers adopted by CVMP in 2018 ............................................ 43
Annex 14 – COMP opinions on designation of orphan medicinal products in 2018 ............................ 48
Annex 15 – HMPC European Union herbal monographs in 2018..................................................... 68
Annex 16 – PDCO opinions and EMEA decisions on paediatric investigation plans and waivers in 2018 ............................................................................................................................................ 70
• Malta John-Joseph BORG (Alternate: Gavril FLORES)
1 Replaced Xavier PRATS-MONNÉ as of October 2018 2 Replaced Svetlin SPIROV as of January 2018 3 Replaced Zdenek BLAHUTA as of June 2018 4 Replaced Birgit NAASE as of April 2018 5 Replaced Despoina MAKRIDAKI as of October 2017 6 Nominated as of June 2018 7 Replaced Belén CRESPO SÁNCHEZ-EZNARRIAGA as of July 2018 8 Replaced Mario MELAZZINI as of November 2018 9 Replaced Nando MINNELLA as of November 2018 10 Replaced Emilia MAVROKORDATOU as of June 2018
EMA/229452/2019 Page 3/126
• Netherlands Hugo HURTS (Alternate: Constant VAN BELKUM)
• Austria Christa WIRTHUMER-HOCHE (Alternate: Thomas REICHHART11)
• Poland Grzegorz CESSAK (Alternate: Marcin KOLAKOWSKI)
• Portugal Rui SANTOS IVO (Alternate: Awaiting nomination)
• Romania Adriana COTEL12 (Alternate: Ada GEORGESCU13)
• Slovenia Momir RADULOVIĆ14 (Alternate: Stanislav PRIMOŽIČ)
• Finland Eija PELKONEN16 (Alternate: Esa HEINONEN)
• Sweden Catarina FORSMAN (Alternate: SARA ROSENMULLER)
• United Kingdom Ian HUDSON (Alternate: Jonathan MOGFORD)
• Representatives of patients' organisations Awaiting nomination Yann LE CAM
• Representative of Wolf-Dieter LUDWIG doctors' organisations
• Representative of Nancy DE BRIYNE veterinarians’ organisations
Observers
• Iceland Runa HAUKSDOTTIR (Alternate: Einar MAGNUSSON)
• Liechtenstein Brigitte BATLINER (Alternate: Martin STRICKER17)
• Norway Audun HÅGÅ (Alternate: Ivar VOLLSET)
11 Replaced Sylvia FÜSZL as of January 2018 12 Replaced Alexandru VELICU as of December 2018 13 Replaced Alexandru VELICU as of March 2018 14 Replaced Andreja CUFAR as of December 2018 15 Nominated as of March 2018 16 Replaced Sinikka RAJANIEMI as of October 2018 17 Replaced Christina ZIMMER as of October 2018
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Annex 2 - Members of the Committee for Medicinal Products for Human Use
Chair: Harald ENZMANN 1 EMA contact: Anabela MARCAL
Members
• Andrea LASLOP (Austria) Alternate: Milena STAIN
• Bart VAN DER SCHUEREN (Belgium) Alternate: Christophe FOCKE
• Mila VLASKOVSKA (Bulgaria) Alternate: Assena STOIMENOVA
• Katarina VUCIC (Croatia) Alternate: Selma ARAPOVIC DZAKULA
• Ewa BALKOWIEC-ISKRA (Poland) Alternate: Marcin KOLAKOWSKI 10 11
1 Elected as Chair as of September 2018, replacing Tomas SALMONSON 2 Replaced Elena KAISI as of June 2018 3 Replaced Hanne LOMHOLT LARSEN as of Febuary 2018 4 Replaced Harald ENZMANN as of October 2018, with a swap of role from alternate to member 5 Replaced Martina WEISE as of November 2018 6 Replaced Eleftheria NIKOLAIDI as of October 2018 7 Replaced Maria ORFANOU as of October 2018, with a swap of role from member to alternate 8 Melinda SOBOR resigned as of June 2018 9 Nominated as of June 2018
• Robert James HEMMINGS (Medical statistics (clinical-trial methodology / epidemiology))
• Blanka HIRSCHLEROVA (Quality (non-biologicals) and Pharmacokinetics) 14 15
• Jan MUELLER-BERGHAUS (Quality and safety (biological), with expertise in advanced therapies (gene, cell and tissue therapies))
• Koenraad NORGA (Pharmacology)
• Sol RUIZ (Quality and safety (biological), with expertise in advanced therapies (gene, cell and tissue therapies))
10 Nominated as of September 2018 11 Aldona PALUCHOWSKA resigned as of May 2018 12 Elected as Vice-Chair as of October 2018, replacing Harald ENZMANN as Vice-Chair 13 Replaced Stanislav PRIMOZIC as of March 2018 14 Nominated as of March 2018 15 Jean-Louis ROBERT resigned as of January 2018
• John Joseph BORG (Malta) 13 Alternate: Benjamin MICALLEF 14
• Menno VAN DER ELST (Netherlands) 15 Alternate: Liana GROSS-MARTIROSYAN 16
1 Elected as Chair as of September 2018, replacing June Munro RAINE 2 Nominated as of April 2018 3 Replaced Caroline LABORDE as of July 2018 4 Elected as Vice-Chair as of October 2018, replacing Almath SPOONER as Vice-Chair 5 Replaced Valerie STRASSMANN as of July 2018 6 Replaced Gudrun Kristin STEINGRIMSDOTTIR as of April 2018 7 Replaced Hrefna GUDMUNSDOTTIR as of April 2018, with swap of role from member to alternate 8 Replaced Almath SPOONER as of July 2018, with swap of role from alternate to member 9 Nominated as of September 2018 10 Replaced Carmela MACCHIARULO as of June 2018, with swap of role from alternate to member 11 Replaced Simona KUDELIENE as of October 2018 12 Replaced Nadine PETITPAIN as of March 2018 13 Replaced Amy TANTI as of April 2018, with swap of role from alternate to member 14 Replaced John Joseph BORG as of April 2018
• Julie WILLIAMS (United Kingdom) Alternate: Patrick BATTY
Independent scientific experts nominated by the European Commission
• Birgitta GRUNDMARK 26
• Daniel MORALES 27
• Hedvig NORDENG 28
• Antoine PARIENTE 29
• Livia PULJAK 30
• Stefan WEILER 31
Members representing healthcare professionals nominated by the European Commission
• Raymond ANDERSON Alternate: Kirsten MYHR
Members representing patients’ organisations nominated by the European Commission
• Marco GRECO Alternate: Albert VAN DER ZEIJDEN
15 Replaced Sabine STRAUS as of September 2018, with swap of role from alternate to member 16 Replaced Menno VAN DER ELST as of September 2018 17 Replaced Kristin Thorseng KVANDE as of May 2018 18 Replaced Roxana DONDERA as of August 2018, who had replaced Nicolae Fotin as from January 2018 19 Replaced Tatiana MAGALOVA as of May 2018 20 Replaced Peter KOREN as of May 2018 21 Replaced Milena RADOHA-BERGOC as of July 2018, with swap of role from alternate to member 22 Replaced Gabriela JAZBEC as of July 2018 23 Replaced Dolores MONTERO CORMINAS as of July 2018, with swap of role from alternate to member 24 Replaced Eva SEGOVIA as of July 2018 25 Replaced Qun-Ying YUE as of July 2018 26 Replaced Thierry TRENQUE as of July 2018 27 Replaced Marie Louise DE BRUIN as of July 2018 28 Replaced Stephen J. W. Evans as of July 2018 29 Replaced Brigitte KELLER-STANISLAWSKI as of July 2018 30 Replaced Herve LE LOUET as of July 2018 31 Replaced Lennart Antero WALDENLIND as of July 2018
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Annex 4 – Members of the Committee for Medicinal Products for Veterinary Use
Chair: David MURPHY (vice-chair: Helen JUKES) EMA contact: Isaura DUARTE
Members and alternates
• Petra FALB (Austria)1 Alternate: Ines Lindner2
• Bruno URBAIN (Belgium) Alternate: Frédéric KLEIN
• Emil KOZHUHAROV (Bulgaria) Alternate: Svetoslav BRANCHEV
• Judita HEDEROVÁ (Slovakia) Alternate: Eva CHOBOTOVÁ
• Katarina ŠTRAUS (Slovenia) Alternate: Maja TURK
1 Replaced Brigitte HAUSER as of October 2018 meeting 2 Replaced Petra FALB as of October 2018 meeting 3 Replaced Martti NEVALAINEN as of February 2018 meeting 4 Replaced Kristina LEHMANN as of February 2018 meeting 5 Replaced João Pedro DUARTE DA SILVA as of December 2018 meeting
6 Swedish member and alternate swapped roles as of May 2018 meeting 7 Replaced Noemi GARCIA DEL BLANCO as of December 2018 meeting 8 Elected in December 2018, replaced Jason WEEKS
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Annex 5 – Members of the Committee on Orphan Medicinal Products
Chair: Violeta STOYANOVA-BENINSKA 1 EMA contact: Anabela MARCAL
Members
• Brigitte BLOECHL-DAUM (Austria)
• Tim LEEST (Belgium)
• Lyubina Racheva TODOROVA (Bulgaria)
• Dinko VITEZIC (Croatia)
• Elena KAISIS (Cyprus) 2
• Katerina KOPECKOVA (Czech Republic)
• Elisabeth PENNINGA (Denmark) 3
• Vallo TILLMANN (Estonia)
• Karri PENTTILA (Finland)
• Annie LORENCE (France)
• Frauke NAUMANN-WINTER (Germany)
• Nikolaos SYPSAS (Greece)
• Zsofia GYULAI (Hungary) 4 5
• Awaiting nomination (Iceland) 6
• Geraldine O’DEA (Ireland)
• Armando MAGRELLI (Italy) (Vice-Chair) 7
• Irena ROGOVSKA (Latvia)
• Ausra MATULEVICIENE (Lithuania)
• Michel HOFFMAN (Luxembourg)
• Robert NISTICO (Malta)
• Elisabeth ROOK (Netherlands) 8
• Ingrid WANG (Norway)
• Bozenna DEMBOWSKA-BAGINSKA (Poland)
• Dinah DUARTE (Portugal) 1 Elected as Chair as of October 2018, replacing Bruno SEPODES 2 Replaced Ioannis KKOLOS as of May 2018 3 Replaced Jens ERSBOLL as of January 2018 4 Nominated as of October 2018 Melinda SOBOR’s mandate ended as of June 2018 5 Melinda SOBOR resigned as of June 2018 6 Sigurdur THORSTEINSSON’s mandate ended as of May 2018 7 Elected as Vice-Chair as of November 2018, replacing Lesley GREENE as Vice-Chair 8 Replaced Violeta STOYANOVA-BENINSKA as from December 2018
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• Olimpia NEAGU (Romania)
• Eva MALIKOVA (Slovakia)
• Martin MOZINA (Slovenia)
• Fernando MENDEZ HERMIDA (Spain)
• Darius MATUSEVICIUS (Sweden)
• Daniel O’CONNOR (United Kingdom)
Members nominated by the European Commission on the EMA’s recommendation
• Ingeborg BARISIC
• Giuseppe CAPOVILLA
• Bruno SEPODES 9 10
Members representing patients' organisations nominated by the European Commission
• Marie Pauline EVERS
• Julian ISLA 11
• Angelo Loris BRUNETTA 12
9 Nominated as of November 2018 10 Kerstin WESTERMARK resigned as of June 2018 Bruno SEPODES mandate started as of November 2018 11 Replaced Lesley GREENE as of June 2018 12 Replaced Mario RICCIARDI as of June 2018
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Annex 6 – Members of the Committee on Herbal Medicinal Products
Chair: Marisa DELBO EMA contact: Anabela MARCAL
Members
• Reinhard LANGER (Austria) Alternate: Astrid OBMANN
• Everaldo ATTARD (Malta) Alternate: Andre MANGANI
• Emiel VAN GALEN (Netherlands) (Vice-chair) Alternate: Burt H. KROES
• Steinar MADSEN (Norway) Alternate: Gro FOSSUM
• Wojciech DYMOWSKI (Poland) Alternate: Katarzyna TOMASZEWSKA
1 Wim HUYGH resigned as of March 2018 2 Iliana IONKOVA became member as of August 2018, with a swap of role from alternate to member 3 Elena MUSTAKEROVA resigned as of April 2018 4 Maria STAVROU’s mandate ended as from April 2018. Eirini PERIKLEOUS replaced Maria STAVROU as from April 2018, with a swap of role from alternate to member. Maria STAVROU replaced Eirini PERIKLEOUS as of June 2018 5 Replaced Eirini PERIKLEOUS as of April 2018 6 Una MOCKLER became alternate as of October 2018, with a swap of role from member to alternate 7 Replaced Rachel Cox as from October 2018, with a swap of role from member to alternate 8 Rachel COX resigned as of August 2018
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• Ana Paula MARTINS (Portugal) Alternate: Eva MENDES
• Linda ANDERSON (United Kingdom) Alternate: Elizabeth GRIFFITHS 14 15
Co-opted members
• Ewa BALKOWIEC ISKRA (Clinical pharmacology) 16
• Heidi FOTH (Toxicology)
• Silvia GIROTTO (Paediatric medicine)
• Gert LAEKEMAN (Experimental/non-clinical pharmacology)
• Maria Helena PINTO FERREIRA (General and family medicine)
Observers
• Ulrich ROSE (EDQM)
• Melanie BALD (EDQM)
9 Replaced Carmen PURDEL as of March 2018, with a swap of role from alternate to member 10 Carmen PURDEL resigned as of February 2018 11 Replaced Raluca IAVORSZKY as of June 2018 12 Raluca IAVORSZKY became member as of March 2018, with a swap of role from alternate to member 13 Replaced Per CLAESON as of January 2018 14 Replaced Sue HARRIS as of September 2018 15 Sue HARRIS resigned as of June 2018 16 Nominated as of June 2018
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Annex 7 – Members of the Committee for Advanced Therapies
Chair: Martina SCHUSSLER-LENZ EMA contact: Patrick CELIS
Members
Members nominated from within the CHMP
• Jan MUELLER-BERGHAUS (Germany) 1 Alternate: Egbert FLORY
• Paolo GASPARINI (Italy) Alternate: Giulio POMPILIO 7 8
• Una RIEKSTINA (Latvia) Alternate: Liga SAULITE 9 10
1 Replaced LUXEMBOURG as member nominated from within CHMP 2 Replaced Ivica MALNAR as of May 2018 3 Replaced Nanna Aaby KRUSE of October 2018, with a swap of role from alternate to member 4 Replaced Anne PASTOFT as of October 2018, with a swap of role from member to alternate 5 Nominated as of April 2018 6 Replaced Krisztian FODOR as of February 2018 7 Replaced LUCA SANGIORGI as of March 2018 8 Luca SANGIORGI’s mandate ended as of January 2018 9 Replaced Aija LINE as of March 2018
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• Guy BERCHEM (Luxembourg) 11 12 Alternate: Anne-Cécile VUILEMIN 13
• Johannes H. OVELGONNE (Netherlands) Alternate: Carla HERBERTS
10 Aija LINE’s mandate ended as from January 2018 11 Replaced Jean-Louis ROBERT as of March 2018, with a swap of role from alternate to member 12 Jean-Louis ROBERT resigned as of January 2018 13 Replaced Guy BERCHEM as of March 2018 14 Replaced Jan KYSELOVIC of May 2018 15 Jan KYSELOVIC replaced Mikulas HRUBISKO as of January 2018, with a swap of role from alternate to member 16 JAN KYSELOVIC became member as of January 2018 17 Replaced Lennart AKERBLOM as of January 2018 18 Nominated as of October 2018
• Brian AYLWARD (Ireland) Alternate: Awaiting nomination
• Sara GALLUZZO (Italy) Alternate: Alessandro JENKNER
• Dina APELE-FREIMANE (Latvia) Alternate: Kristine SUPE
• Sigita BUROKIENE (Lithuania) Alternate: Goda VAITKEVICIENE
• John Joseph BORG (Malta) Alternate: Herbert LENICKER
• Maaike VAN DARTEL (Netherlands) Alternate: Awaiting nomination
• Siri WANG (Norway) Alternate: Anette Solli KARLSEN 5
• Marek MIGDAL (Poland) Alternate: Awaiting nomination 6
1 Melinda SOBOR resigned as of June 2018 2 Nominated as of February 2018 3 Replaced Maija PIHLAJAMAKI as of April 2018 4 Replaced Immanuel BARTH as of September 2018 5 Replaced Ine SKOTTHEIM RUSTEN as of January 2018
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• Helena FONSECA (Portugal) Alternate: Hugo TAVARES
• Peter SISOVSKY (Slovakia) Alternate: Awaiting nomination
• Stefan GROSEK (Slovenia) Alternate: Janez JAZBEC
• Fernando DE ANDRES TRELLES (Spain) Alternate: Maria Jesus FERNANDES CORTIZO
• Ninna GULLBERG (Sweden) Alternate: Eva AGURELL
• Angeliki SIAPKARA (United Kingdom) Alternate: Martina RIEGL
Members representing healthcare professionals nominated by the European Commission
• Francesca ROCCHI Alternate: Catherine CORNU
• Fernando CABANAS Alternate: Jorrit GERRITSEN 7 8
• Johannes TAMINIAU Alternate: Doina PLESCA
Members representing patients' organisations nominated by the European Commission
EMA/CHMP/805498/2016 Dabigatran etexilate hard capsule
75 mg, 110 mg and 150 mg
product-specific bioequivalence
guidance
Final 31 May 2018
EMA/229452/2019 Page 32/126
Reference number Document Status Date
EMA/CHMP/315234/2014/
Rev.1
Tadalafil film-coated tablets 2.5
mg, 5 mg, 10 mg and 20 mg
product-specific bioequivalence
guidance
Final 25 January 2018
EMA/CHMP/158772/2016/
Rev.1
Prasugrel hydrochloride film-coated
tablets 5 mg and 10 mg product-
specific bioequivalence guidance
Final 31 May 2018
EMA/CHMP/154812/2016/
Rev.1
Paliperidone prolonged-release
tablet 1.5 mg, 3 mg, 6 mg, 9 mg
and 12 mg product-specific
bioequivalence guidance
Final 31 May 2018
Quality Working Party
Reference number Document Status Date
EMA/CHMP/CVMP/QWP/49
6873/2018
Guideline on the quality of water
for pharmaceutical use
Adopted for
consultation
28 June 2018
CHMP/QWP/227/02 Rev 4
EMEA/CVMP/134/02-Rev.
4
Guideline on Active Substance
Master File Procedure
Adopted 18 October 2018
EMA/CHMP/CVMP/QWP/85
0374/2015
Guideline on the sterilisation of the
medicinal product, active
substance, excipient and primary
container
Adopted 15 November 2018
EMA/CHMP/QWP/708282/2
018
Guideline on quality and
equivalence of topical
products
Adopted for
consultation
15 November 2018
EMA/CVMP/QWP/798401/2
015
Guideline on manufacture
veterinary finished dosage form
Adopted for
consultation
15 February 2018
EMA/CVMP/QWP/153641/2
018
Draft reflection paper on risk
management requirements for
elemental impurities in veterinary
medicinal products
Adopted for
consultation
8 November 2018
Radiopharmaceutical Drafting Group
Reference number Document Status Date
None
Respiratory Drafting Group
Reference number Document Status Date
None
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Rheumatology/Immunology Working Party
Reference number Document Status Date
EMA/CHMP/481820/2018
Corr.
Concept paper on the need to
develop a reflection paper on
development of medicinal products
to prevent and treat acute kidney
injury
Draft for public
consultation
28 June 2018
EMA/CHMP/251023/2018 Concept paper on a Guideline for
allergen products development in
moderate to low-sized study
population
Draft for public
consultation
13 December 2018
Safety Working Party
Reference number Document Status Date
EMA/CHMP/SWP/686140/2
018
Guideline on the non-clinical
requirements for
radiopharmaceuticals
Draft for public
consultation
15 November 2018
EMA/CHMP/SWP/545588/2
017
Reflection paper on the
qualification of non-genotoxic
impurities
Draft for public
consultation
15 November 2018
EMEA/CHMP/SWP/4447/00
Rev.1
Environmental risk assessment of
medicinal products for human use
Draft for public
consultation
15 November 2018
Vaccines Working Party
Reference number Document Status Date
EMEA/CHMP/VWP/164653/
05
Guideline on Clinical Development
of new vaccines
Draft for public
consultation
26 April 2018
EMA/CHMP/257022/2017 Guideline on the evaluation of
medicinal products indicated for
the prophylaxis or treatment of
respiratory syncytial virus (RSV)
disease
Final 18 October 2018
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Annex 12 – CVMP opinions on medicinal products for veterinary use in 2018
Positive opinions
Product
• Invented name • INN/Common
name
Marketing
authorisation
holder
Therapeutic area
• Target species • Summary of
indication
EMA/CVMP
• Validation • Opinion • Active time • Clock stop
European
Commission
• Opinion received
• Transmission to EC
• Decision • Notification • Official
Journal • Clevor
• ropinirole
Orion Corporation • Dogs
• Induction of
vomiting in dogs
• 19/10/2016
• 15/02/2018
• 210
• 274
• 15/02/2018
• 13/03/2018
• 13/04/2018
• 17/04/2018
• C 188
01/06/2018
• Bravecto Plus
• fluralaner/moxidect
in
Intervet
International B.V.
• Cats
• For the treatment of
tick and flea
infestations in cats.
For the prevention
of heartworm
disease caused by
Dirofilaria immitis in
cats. For the
treatment of
infections with
intestinal
roundworm and
hookworm in cats.
The veterinary
medicinal product is
exclusively indicated
when use against
ticks or fleas and
one or more of the
other target
parasites is indicated
at the same time.
• 13/12/2016
• 15/03/2018
• 210
• 247
• 15/03/2018
• 11/04/2018
• 08/05/2018
• 16/05/2018
• C 229
29/06/2018
• Dany’s BienenWohl
• oxalic acid
dihydrate
Dany’s
BienenWohl
GmbH
• Honey bees
• For the treatment of
varroosis
• 19/02/2018
• 19/04/2018
• 59
• 0
• 19/04/2018
• 08/05/2018
• 14/06/2018
• 19/06/2018
• C 266
27/07/2018
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Product
• Invented name • INN/Common
name
Marketing
authorisation
holder
Therapeutic area
• Target species • Summary of
indication
EMA/CVMP
• Validation • Opinion • Active time • Clock stop
European
Commission
• Opinion received
• Transmission to EC
• Decision • Notification • Official
Journal • Ubac
• Streptococcus
uberis vaccine
(inactivated)
Laboratorios
Hipra, S.A.
• Cattle
• For active
immunisation of
healthy cows and
heifers to reduce the
incidence of clinical
intramammary
infections caused by
Streptococcus
uberis, to reduce the
somatic cell count in
Streptococcus uberis
positive quarter milk
samples and to
reduce milk
production losses
caused by
Streptococcus uberis
intramammary
infections.
• 15/03/2017
• 25/05/2018
• 210
• 226
• 25/05/2018
• 21/06/2018
• 26/07/2018
• 30/07/2018
• C 309
31/08/2018
• Arti-Cell Forte1
• chondrogenic
induced equine
allogeneic
peripheral blood-
derived
mesenchymal stem
cells
Global Stem cell
Technology NV
• Horses
• Reduction of mild to
moderate recurrent
lameness associated
with non-septic joint
inflammation in
horses.
• 13/07/2017
• 21/06/2018
• 210
• 134
• 21/06/2018
• Pending
• Pending
• Pending
• Pending
• Cortacare
• hydrocortisone
aceponate
Ecuphar NV • Dogs
• For symptomatic
treatment of
inflammatory and
pruritic dermatoses
in dogs
• 07/06/2017
• 21/06/2018
• 210
• 169
• 21/06/2018
• 25/07/2018
• 27/08/2018
• 29/08/2018
• C 349
28/09/2018
• Isemid
• TORASEMIDE
CEVA Santé
Animale
• Dogs
• For treatment of
clinical signs related
to congestive heart
failure in dogs,
• 12/07/2017
• 08/11/2018
• 210
• 274
• 08/11/2018
• 05/12/2018
• 09/01/2019
• 11/01/2019
• C 80
1 Under re-consideration following request from EC
EMA/229452/2019 Page 36/126
Product
• Invented name • INN/Common
name
Marketing
authorisation
holder
Therapeutic area
• Target species • Summary of
indication
EMA/CVMP
• Validation • Opinion • Active time • Clock stop
European
Commission
• Opinion received
• Transmission to EC
• Decision • Notification • Official
Journal including pulmonary
oedema.
04/03/2019
• Syvazul BTV
• Bluetongue virus
vaccine
(inactivated)
(multistrain: 1-2
strains out of a set
of 3)
LABORATORIOS
SYVA, S.A.U
• Sheep, Cattle
• For active
immunisation of
sheep and cattle
against bluetongue
virus serotypes 1, 4
and/or 8
(combination of
maximum 2
serotypes)
• 10/05/2017
• 08/11/2018
• 210
• 337
• 08/11/2018
• 05/12/2018
• 09/01/2018
• 11/01/2019
• C 80
04/03/2019
• EVANT
• Coccidiosis vaccine
live for chickens
LABORATORIOS
HIPRA, S.A.
• Chickens
• For active
immunisation of
chicks from 1 day of
age against
coccidiosis.
• 20/12/2017
• 06/12/2018
• 210
• 141
• 06/12/2018
• 07/01/2019
• 05/02/2019
• Pending
• Pending
• Kriptazen
• HALOFUGINONE
Virbac S.A. • Newborn calves
• In new born calves
prevention of
diarrhoea due to
diagnosed
Cryptosporidium
parvum, in farms
with history of
cryptosporidiosis
and reduction of
diarrhoea due to
diagnosed
Cryptosporidium
parvum.
• 21/02/2018
• 06/12/2018
• 210
• 78
• 06/12/2018
• 10/01/2019
• 08/02/2019
• Pending
• Pending
EMA/229452/2019 Page 37/126
Negative opinions
Product
• Invented name • INN/Common
name
Marketing
authorisation
holder
Therapeutic area
• Target species • Summary of
indication
EMA/CVMP
• Validation • Opinion • Active time • Clock stop
European
Commission
• Opinion received
• Transmission to EC
• Decision • Notification • Official
Journal • Horse Allo2
• Allogeneic equine
adipose-derived
mesenchymal stem
cells
Centauri Biotech
SL
• Horses
• For the treatment
osteoarthritis in
adult non-food
producing horses.
Demonstration of
efficacy is based on
a randomised
controlled trial
evaluating the
efficacy of the
treatment in horses
with osteoarthritis.
• 12/01/2017
• 21/06/2018
• Pending
• Pending
• 21.06.2018
• Pending
• Pending
• Pending
• Pending
• HorStem3
• Equine umbilical
cord mesenchymal
stem cells
EquiCord-Ymas
S.L.
• Horses
• Treatment of clinical
symptomatology,
lameness grade,
synovial effusion
and flexion pain,
associated with mild
to moderate
degenerative joint
disease
(ostheoathrosis) in
horses.
Demonstration of
efficacy is based on
a randomised
controlled clinical
trial evaluation the
efficacy of the
product in equines
with mild to
moderate
ostheoathrosis.
• 08/06/2016
• 11/10/2018
• Pending
• Pending
• 11/10/2018
• Pending
• Pending
• Pending
• Pending
2 Under re-consideration following request from EC 3 Under re-examination
EMA/229452/2019 Page 38/126
Product
• Invented name • INN/Common
name
Marketing
authorisation
holder
Therapeutic area
• Target species • Summary of
indication
EMA/CVMP
• Validation • Opinion • Active time • Clock stop
European
Commission
• Opinion received
• Transmission to EC
• Decision • Notification • Official
Journal • Longrange
• eprinomectin
Merial • Cattle
• Treatment of the
following parasites:
Gastrointestinal
Roundworms (Adult
and L4): Ostertagia
ostertagi/lyrata,
Cooperia
oncophora/surnabad
a, C. punctata,
Haemonchus
contortus,
Trichostrongylus
axei, T.
colubriformis,
Bunostomum
phlebotomum,
Nematodirus
helvetianus,
Oesophagostomum
radiatum
• Lungworm (Adults
and L4):
Dictyocaulus
viviparus
• Warbles (parasitic
stages): Hypoderma
bovis, H. lineatum
• Mange mites:
Sarcoptes scabiei
var. bovis
• Lice: Linognathus
vituli, Haematopinus
eurysternus,
Solenoptes capillatus
• Horn flies:
Haematobia irritans
• Prevention of
reinfections with the
following parasites:
• Dictyocaulus
• 12/01/2017
• 21/06/2018
• 210
• 315
• 11/10/2018
• N/a
• 12/12/2018
• 14/12/2018
• C 32
25/01/2019
EMA/229452/2019 Page 39/126
Product
• Invented name • INN/Common
name
Marketing
authorisation
holder
Therapeutic area
• Target species • Summary of
indication
EMA/CVMP
• Validation • Opinion • Active time • Clock stop
European
Commission
• Opinion received
• Transmission to EC
• Decision • Notification • Official
Journal viviparus, Ostertagia
ostertagi/lyrata,
Trichostrongylus
colubriformis,
Haemonchus
contortus, and
Bunostomum
phlebotomum;
• Oesophagostomum
radiatum, Cooperia
oncophora/surnabad
a, C. punctata and
Trichostrongylus
axei.
CVMP opinions in 2018 on establishment of MRLs
Positive opinions
Product
• Substance
Target species EMA/CVMP
• Validation • Opinion • Active time • Clock stop
European
Commission
• Opinion received • Regulation • Official Journal
• Paromomycin Poultry eggs • 13/07/2016
• 15/02/2018
• 15/02/2018
• 2018/1967
• L 316
• Isoflurane Porcine • 10/05/2017
• 15/03/2018
• 15/03/2018
• 2018/1076
• L 194
• Diflubenzuron Salmonidae • 12/06/2014
• 15/03/2018
• 15/03/2018
• Pending
• Pending
• Ovotransferrin Chicken and poultry • 07/06/2017
• 19/07/2018
• 19/07/2018
• 2019/83
• L 39
EMA/229452/2019 Page 40/126
Negative opinions
There were not negative opinions on establishment of MRLs in 2018.
CVMP opinions on extensions of indication for medicinal products for veterinary use
Product • Brandname • INN
Marketing authorisation holder
Therapeutic Area • ATC Code • Summary of indication
EMA/CVMP opinion
European Commission decision date
• Advocate
• imidacloprid /
moxidectin
• Bayer
Animal
Health
GmbH
• QP54AB52
• For dogs, cats and ferrets
suffering from, or at risk from,
mixed parasitic infections.
• 18/01/2018 • 20/02/2018
• AFTOVAXPUR
DOE
• Foot-and-
mouth disease
vaccine
(inactivated)
(multistrain:
1-3 strains out
of a set of 8)
• MERIAL • QI02AA04
• Active immunisation of cattle,
sheep and pigs from 2 weeks
of age against foot-and-mouth
disease to reduce clinical signs.
• 08/11/2018 • 12/12/2018
• ERAVAC
• rabbit
haemorrhagic
disease type 2
virus
(RHDV2),
inactivated
• Laboratorios
Hipra, S.A.
• QI08AA01
• For active immunisation of
rabbits against rabbit
haemorrhagic disease type 2
virus (RHDV2)
• 15/02/2018 • 22/03/2018
EMA/229452/2019 Page 41/126
Product • Brandname • INN
Marketing authorisation holder
Therapeutic Area • ATC Code • Summary of indication
EMA/CVMP opinion
European Commission decision date
• Onsior
• robenacoxib
• Elanco
GmbH
• QM01AH91
• Relief of pain and inflammation
associated with acute and
chronic musculo-skeletal
disorders in cats. For the
reduction of moderate pain
and inflammation associated
with orthopaedic surgery in
cats.
• Treatment of pain and
inflammation associated with
chronic osteoarthritis in dogs.
• Treatment of pain and
inflammation associated with
orthopaedic or soft tissue
surgery in dogs and with soft
tissue surgery in cats. For the
treatment of pain and
inflammation associated with
orthopaedic or soft tissue
surgery in cats.
• 15/03/2018 • 26/04/2018
• Panacur
AquaSol
• fenbendazole
• Intervet
Internationa
l B.V.
• QP52AC13
• For the treatment and control
of gastro-intestinal nematodes
in pigs. For the treatment of
gastro-intestinal nematodes in
chickens.
• 18/01/2018 • 20/03/2018
• Pexion
• imepitoin
• Boehringer
Ingelheim
Vetmedica
GmbH
• QN03AX90
• For the reduction of the
frequency of generalised
seizures due to idiopathic
epilepsy in dogs for use after
careful evaluation of
alternative treatment options.
For the reduction of anxiety
and fear associated with noise
phobia in dogs.
• 25/05/2018 • 05/07/2018
EMA/229452/2019 Page 42/126
Product • Brandname • INN
Marketing authorisation holder
Therapeutic Area • ATC Code • Summary of indication
EMA/CVMP opinion
European Commission decision date
• Porcilis PCV M
Hyo
• porcine
circovirus type
2 orf2 subunit
antigen /
mycoplasma
hyopneumonia
e inactivated,
strain atcc
25934
• Intervet
Internationa
l B.V.
• QI09AL
• For the active immunisation of
pigs to reduce viremia, virus
load in lungs and lymphoid
tissues, virus shedding caused
by PCV2 infection, and severity
of lung lesions caused by
Mycoplasma hyopneumoniae
infection
• 25/05/2018 • 27/06/2018
• Vectormune
ND
• cell-associated
live
recombinant
turkey herpes
virus
(rHVT/ND)
expressing the
fusion protein
of Newcastle
diseases virus
D-26
lentogenic
strain
• Ceva-
Phylaxia
Co.Ltd
• QI01AD
• For active immunisation of 18
day-old embryonated chicken
eggs or one-day-old chicks to
reduce mortality and clinical
signs caused by Newcastle
disease virus and to reduce
mortality, clinical signs and
lesions caused by Marek’s
disease virus with a phenotype
‘virulent’.
• 18/01/2018 • 20/02/2018
EMA/229452/2019 Page 43/126
Annex 13 – Guidelines and concept papers adopted by CVMP in 2018
CVMP quality
Reference number Document title Status
EMA/CVMP/QWP/798401/2015 Guideline on Manufacture of the veterinary finished dosage form
Adopted for consultation February 2018 (End of consultation 31 August 2019)
EMA/CHMP/CVMP/QWP/496873/2018
Guideline on the quality of water for pharmaceutical use
Adopted for consultation July 2018 (End of consultation 15 May 2019)
EMA/CVMP/QWP/153641/2018 Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products
Adopted for consultation November 2018 (End of consultation 31 August 2019)
EMEA/CVMP/134/02 Rev 4 Guideline on Active Substance Master File Procedure
Adopted November 2018
EMA/CHMP/CVMP/QWP/850374/2015
Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container
Adopted December 2018
CVMP safety
Reference number Document title Status
EMA/CVMP/SWP/779037/2017 Concept paper for the revision of the guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
Adopted for consultation January 2018 (End of consultation 28 February 2018)
EMA/CVMP/SWP/721059/2014 Guideline on user safety of topically administered veterinary medicinal products
Adopted April 2018
EMA/CHMP/CVMP/SWP/246844/2018
Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’
Adopted April 2018
EMA/CVMP/ERA/103555/2015 Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater
EMA/CVMP/SWP/735325/2012 Guideline on determination of withdrawal periods for edible tissues
Adopted September 2018
EMA/CVMP/SWP/66781/2005-Rev.2
Revised guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
Adopted for consultation December 2018 (End of consultation 31 August 2019)
EMA/CVMP/SWP/377245/2016 Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products
Adopted December 2018
CVMP efficacy
Reference number Document title Status
EMA/CVMP/383441/2005-Rev.1 Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances
Adopted for consultation April 2018 (End of consultation 30 September 2018)
EMA/CVMP/EWP/278031/2015 Guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector- borne diseases in dogs and cats
Adopted for consultation July 2018 (End of consultation 31 August 2019)
EMA/CVMP/EWP/310225/2014 Reflection paper on resistance in ectoparasites
Adopted for consultation September 2018 (End of consultation 31 August 2019)
EMA/CVMP/016/2000-Rev.3 Guideline on the conduct of bioequivalence studies for veterinary medicinal products
Adopted December 2018
EMA/CVMP/EWP/755916/2016 Guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances
Adopted for consultation December 2018 (End of consultation 31 August 2019)
EMA/CVMP/EWP/77872/2018 Questions and answers on the CVMP guideline on the “Guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees”
EMA/CVMP/PhVWP/171122/2016 Revised recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data for centrally authorised products (CAPs)
Adopted May 2018
EMA/CVMP/PhVWP/10418/2009-Rev10
Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products
Adopted June 2018
EMA/CVMP/PhVWP/288284/2007-Rev.11
Guidance notes on the use of VeDDRA terminology for reporting suspected adverse reactions in animals and humans
Adopted June 2018
EMA/CVMP/PhVWP/145186/2013 Q&A on adverse event reporting Adopted June 2018
EMA/CVMP/PhVWP/126661/2009 Q&A on preparation, management and assessment of periodic safety update reports (PSURs)
Adopted June 2018
CVMP antimicrobials
Reference number Document title Status
EMA/CVMP/383441/2005-Rev.1 Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances
Adopted for consultation April 2018 (End of consultation 30 September 2018)
EMA/CVMP/AWP/721118/2014 Reflection paper on use of aminoglycosides in animals in the European Union: development of resistance and impact on human and animal health
Adopted June 2018
EMA/CVMP/AWP/706442/2013 Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals
Adopted for consultation July 2018 (End of consultation 31 October 2018)
EMA/CVMP/849775/2017 Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation
Adopted for consultation July 2018 (End of consultation 31 January 2019)
EMA/CVMP/AWP/842786/2015 Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health
Adopted for consultation September 2018 (End of consultation 21 December 2019)
EMA/CVMP/AWP/237294/2017 Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union
Adopted November 2018
CVMP immunologicals
Reference number Document title Status
EMA/CVMP/IWP/315887/2017 Guideline on the use of adjuvanted veterinary vaccines
Adopted for consultation June 2018 (End of consultation 15 January 2019)
EMA/CVMP/IWP/105506/2007-Rev.1
Revised guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD)
Adopted December 2018
EMA/CVMP/IWP/170689/2016 Guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats
Adopted for consultation December 2018 (End of consultation 31 August 2019)
CVMP environmental risk assessment
Reference number Document title Status
EMEA/CVMP/ERA/172074/2008 Rev. 6
Questions and Answers on the implementation of the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH GL6 (Phase I) and GL38 (Phase II)
Adopted January 2018
EMA/CVMP/ERA/103555/2015 Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater
Adopted April 2018
EMA/CVMP/ERA/632109/2014 Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products
Adopted for consultation November 2018 (End of consultation 31 August 2019)
No guidelines or working documents have yet been agreed in 2018.
Replacement, Reduction, Refinement of animal testing (3Rs)
Reference number Document title Status
EMA/CHMP/CVMP/3Rs/677407/2015
Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken
Adopted June 2018
EMA/CHMP/CVMP/3Rs/164002/2016
Reflection paper providing an overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs
Adopted June 2018
General
Reference number Document title Status
EMA/CVMP/VICH/517152/2013 VICH GL57: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species
Adopted for consultation January 2018 (End of consultation 15 June 2018)
EMA/CVMP/VICH/335918/2016 VICH GL58 Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
Adopted for consultation July 2018 (End of consultation 31 December 2018)
EMA/CVMP/VICH/176637/2014 VICH GL56 on Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods
Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues
Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII
Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues
1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt
Pharm Research Associates (UK) Limited - United Kingdom
Treatment of acute myeloid leukaemia
• 22/02/2018/ • 25/07/2018/ • (93 days/28
days)
• 27/07/2018 • 24/08/2018
Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2
Omeros London Limited - United Kingdom
Treatment in haematopoietic stem cell transplantation
Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII
Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA
Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1
Tucatinib W Oncology Cascadian Therapeutics Luxembourg S.A.R.L.
30/01/2018 P/0036/2018
Tenofovir alafenamide Vemlidy W Infectious Diseases Gilead Sciences International Ltd.
30/01/2018 P/0037/2018
Recombinant human epidermal growth factor
W Endocrinology-Gynaecology-Fertility-Metabolism, Other
Praxis Pharmaceuticals S.A
30/01/2018 P/0038/2018
Rosuvastatin (calcium)/ acetylsalicylic acid
W Cardiovascular Diseases Adamed Sp. z o.o. 16/02/2018 P/0039/2018
EMA/229452/2019 Page 74/126
Active Substance(s) Invented Name PDCO Opinion
Therapeutic areas Applicant Decision date
Decision Number
Recombinant Neisseria meningitidis group B NHBA fusion protein / recombinant Neisseria meningitidis group B NadA protein / recombinant Neisseria meningitidis group B fHbp fusion protein / Outer Membrane Vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4
Pembrolizumab KEYTRUDA PM Oncology Merck Sharp & Dohme (Europe), Inc.
16/02/2018 P/0043/2018
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage
W Ophthalmology Shire Pharmaceuticals Ireland Limited
07/05/2018 P/0134/2018
Ibuprofen / paracetamol W Other Pain
Farmalíder, S.A. 07/05/2018 P/0135/2018
Inebilizumab PM Neurology MedImmune, LLC (affiliate of AstraZeneca)
07/05/2018 P/0136/2018
Galcanezumab PM Neurology Eli Lilly and Company Limited
07/05/2018 P/0137/2018
Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm. f. (fresh fruit), Paullinia cupana Kunth, Theobroma cacao L.
Bimekizumab P Dermatology UCB Biopharma SPRL 17/07/2018 P/0193/2018
Expanded donor-derived allogenic T cells transduced with the retroviral vector expressing the transgenes for inducible caspase9 and the truncated CD19 selectable marker (BPX-501)
PM Immunology-Rheumatology-Transplantation
Bellicum Pharma Ltd 17/07/2018 P/0194/2018
Fostamatinib W Other Rigel Pharmaceuticals Ltd
17/07/2018 P/0195/2018
Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21)
Velphoro PM Uro-nephrology Vifor Fresenius Medical Care Renal Pharma France
Itacitinib P Immunology-Rheumatology-Transplantation
Incyte Biosciences UK Ltd.
17/07/2018 P/0208/2018
Palbociclib Ibrance P Oncology Pfizer Limited 17/07/2018 P/0209/2018
Mexiletine (hydrochloride) PM Other Lupin (Europe) Ltd. 17/07/2018 P/0210/2018
EMA/229452/2019 Page 90/126
Active Substance(s) Invented Name PDCO Opinion
Therapeutic areas Applicant Decision date
Decision Number
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage
Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274)
Mirikizumab P Dermatology Eli Lilly and Company 12/09/2018 P/0283/2018
EMA/229452/2019 Page 97/126
Active Substance(s) Invented Name PDCO Opinion
Therapeutic areas Applicant Decision date
Decision Number
Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor (TBX-1400)
P Immunology-Rheumatology-Transplantation
Taiga Biotechnologies, Inc
12/09/2018 P/0284/2018
Human fibrinogen concentrate (BT524) PM Haematology-Hemostaseology
Biotest AG 12/09/2018 P/0285/2018
Recombinant human alpha-galactosidase A (PRX 102)
PM Endocrinology-Gynaecology-Fertility-Metabolism
Protalix Ltd 12/09/2018 P/0286/2018
Sarizotan (hydrochloride) P Neurology Newron Pharmaceuticals SpA
12/09/2018 P/0287/2018
Vamorolone PM Other ReveraGen BioPharma Ltd
12/09/2018 P/0288/2018
Palovarotene PM Other Clementia Pharmaceuticals Inc.
12/09/2018 P/0289/2018
Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, subfamily D, member 1 (ABCD1) cDNA
PM Neurology bluebird bio France 12/09/2018 P/0290/2018
Baricitinib Olumiant P Dermatology Eli Lilly and Company Limited
12/09/2018 P/0291/2018
Indacaterol (acetate) / mometasone (furoate)
PM Pneumology - Allergology
Novartis Europharm Limited
12/09/2018 P/0292/2018
Ponatinib Iclusig PM Oncology Incyte Biosciences Distribution B.V
Brexpiprazole PM Psychiatry Otsuka Europe Development and Commercialisation Limited, Zweigniederlassung,
12/09/2018 P/0316/2018
EMA/229452/2019 Page 100/126
Active Substance(s) Invented Name PDCO Opinion
Therapeutic areas Applicant Decision date
Decision Number
Frankfurt am Main
Arimoclomol citrate W Neurology Orphazyme A/S 12/09/2018 P/0317/2018
Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain
P Infectious Diseases Vaccines
Janssen-Cilag International NV
12/09/2018 P/0318/2018
Recombinant human acid ceramidase (RVT-801)
P Other Enzyvant Farber Ireland Ltd
12/09/2018 P/0319/2018
Afatinib Giotrif P Oncology Boehringer Ingelheim International GmbH
12/09/2018 P/0320/2018
Inclisiran sodium P Endocrinology-Gynaecology-Fertility-Metabolism
The Medicines Company UK Ltd.
12/09/2018 P/0321/2018
Rilpivirine (hydrochloride) EDURANT PM Infectious Diseases Janssen-Cilag International NV
Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2) / Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage) / Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) / Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
Pemigatinib W Oncology Incyte Biosciences Distribution B.V.
06/12/2018 P/0386/2018
EMA/229452/2019 Page 108/126
Active Substance(s) Invented Name PDCO Opinion
Therapeutic areas Applicant Decision date
Decision Number
Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1) / Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2) / Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage) / Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc]
PM Vaccines Seqirus UK Limited 06/12/2018 P/0387/2018
Liposomal combination of cytarabine and daunorubicin
Vyxeos PM Oncology Jazz Pharmaceuticals Ireland Limited
07/12/2018 P/0388/2018
Lenvatinib LENVIMA Kisplyx
PM Oncology Eisai Europe Ltd 07/12/2018 P/0389/2018
31 Expenditure on business related IT projects 20,064 6.5% 15,457 4.6% 13,798 4.5%
Total Title 3 151,667 49.3% 155,838 46.1% 142,721 46.6%TOTAL EXPENDITURE 307,824 100.0% 337,761 100.0% 306,537 100.0%
1 Financial Year 2017: as per final accounts; rounded to nearest thousand Euro2 Financial Year 2018: as per final budget3 Financial Year 2018: as per provisional accounts; rounded to nearest thousand Euro
2017 (final)1 2018 (budget)2 2018 (prov.)3
EMA/229452/2019 Page 117/126
Annex 20 – European Medicines Agency Establishment Plan
Category and grade
TEMPORARY POSTS
POSTS 2018 POSTS 2019
Authorised Actual as per 31.12.2018 Authorised
Permanent posts
Temporary posts
Permanent posts
Temporary posts
Permanent posts
Temporary posts
AD 16 - 0 - 0 - 0
AD 15 - 3 - 3 - 3
AD 14 - 7 - 6 - 7
AD 13 - 11 - 11 - 11
AD 12 - 43 - 42 - 43
AD 11 - 43 - 43 - 43
AD 10 - 41 - 41 - 43
AD 9 - 45 - 45 - 43
AD 8 - 59 - 59 - 59
AD 7 - 65 - 65 - 65
AD 6 - 23 - 23 - 37
AD 5 - 0 - 0 - 11
Total AD 0 340 0 338 0 365
AST 11 - 2 - 2 - 2
AST 10 - 7 - 7 - 7
AST 9 - 6 - 5 - 7
AST 8 - 16 - 16 - 16
AST 7 - 22 - 22 - 22
AST 6 - 42 - 39 - 27
AST 5 - 46 - 43 - 35
AST 4 - 57 - 57 - 57
AST 3 - 46 - 46 - 46
AST 2 - 7 - 60 - 7
AST 1 - 0 - 0 - 0
Total AST 0 251 0 243 0 226
Grand Total 0 591 0 581 0 591
Other staff Planned (FTE1) 2018
Actual (FTE1) 2018
Actual headcount 31.12.2018
Planned (FTE1) 2019
CONTRACT AGENTS 180 159 170 233
NATIONAL EXPERTS 39 32 30 30
1 FTE=Full Time Equivalent
EMA/229452/2019 Page 118/126
Annex 21 – Access to documents requests in 2018
Requests received and pages released
Year Number of requests received Number of pages released
2018 822 441,720
Initial decisions on access in 20181
Access given
Yes 562
Partial 18
No 40
Not Applicable2 193
Total closed 813
Pending 267
Legal basis used for full or partial refusal
Legal basis Full Partial
4.1(a) – Protection of public interest
0 1
4.1(b) – Protection of privacy 1 0
4.2 1st ind – Protection of commercial interest
23 18
4.2 2nd ind – Protection of court proceedings
0 0
4.2 3rd ind – Protection of inspections
5 1
4.3 1st par – Protection of decision making process
12 4
4.3 2nd par – Protection of the Agency’s decision making process
0 0
4.5 – Protection of Member States 0 0
Total 41 24
1 Including initial requests received in previous years but closed in 2018 2 Request became RFI / Document is not held by the Agency / Clarification is not received / Withdrawn
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Decision on confirmatory applications in 20183
Appeals
Final refusal 2
Release 5
Partial 0
Not Applicable4 3
Total closed 10
Pending 0
Legal basis used for full or partial refusal
Legal basis Full Partial
4.1(a) – Protection of public interest
0 0
4.1(b) – Protection of privacy 0 0
4.2 1st ind – Protection of commercial interest
0 0
4.2 2nd ind – Protection of court proceedings
0 0
4.2 3rd ind – Protection of inspections
2 0
4.3 1st par – Protection of decision making process
0 0
4.3 2nd par – Protection of the Agency’s decision making process
0 0
4.5 – Protection of Member States 0 0
Total 2 0
3 Including appeals received in previous years but closed in 2018 4 Withdrawn
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Affiliation (per initial requests and appeals in 2018)
Affiliation Number of requests received
In % Number of pages released5
In %
Not-for-profit organisation 10 1 13,788 3
EU Institution (EC etc) 2 0 48 0
Regulator outside EU 1 0 0 0
EU NCA 0 0 17 0
Patients or Consumer 100 12 107,222 24
Healthcare professional 36 4 48,382 11
Academia/Research institute
63 8 103,587 23
Legal 70 9 21,402 5
Media 35 4 17,603 4
Pharmaceutical industry 385 47 111,130 25
Consultant 119 14 18,541 4
Other 1 0 0 0
Total 822 100 441,720 100
5 Including initial requests and appeals received in previous years but closed in 2018
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Annex 22 – Publications by Agency staff members and experts in 2018
Aartsma-Rus A, Mercuri E, Vroom E, Balabanov P. Meeting report of the "Regulatory Exchange Matters" session at the 5th International TREAT-NMD Conference: Lessons in communication: How an early dialogue between patients, regulators and academics can further therapy development for neuromuscular disorders Freiburg, Germany, 27-29 November 2017. Neuromuscul Disord. 2018 Jul;28(7):619-623. doi: 10.1016/j.nmd.2018.04.009. Epub 2018 Apr 20.
Alteri E, Guizzaro L. Be open about drug failures to speed up research Nature. 2018 Nov;563(7731):317-319
Amaouche N, Casaert Salomé H, Collignon O, Santos MR, Ziogas C Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes. Drug Discov Today. 2018 Oct;23(10):1801-1805
Arlett P. Rapid response to: Pandemrix vaccine: why was the public not told of early warning signs? BMJ 2018;362:k3948
Bahri P, Castillon Melero M. Listen to the public and fulfil their information interests – translating vaccine communication research findings into guidance for regulators Br J Clin Pharmacol. 2018 Aug;84(8):1696-1705. doi: 10.1111/bcp.13587. Epub 2018 May 31.
Bec G, Strecenski I, Castelnovo T. Marketing authorisation holder’s compliance with post-authorisation obligations in the European Union: a 5-year review Regulatory Rapporteur - Vol 15, No 11: 27-32
Blind E, Janssen H, Dunder K, de Graeff PA. The European Medicines Agency's approval of new medicines for type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2059-2063. doi: 10.1111/dom.13349. Epub 2018 May 30.
Bonertz A, Roberts GC, Hoefnagel M, Timon M, Slater JE, Rabin RL, Bridgewater J, Pini C, Pfaar O, Akdis C, Goldstein J, Poulsen LK, van Ree R, Rhyner C, Barber D, Palomares O, Sheikh A, Pawankar R, Hamerlijnk D, Klimek L, Agache I, Angier E, Casale T, Fernandez-Rivas M, Halken S, Jutel M, Lau S, Pajno G, Sturm G, Varga EM, Gerth van Wijk R, Bonini S, Muraro A, Vieths S. Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products. Allergy. 2018 Jan;73(1):64-76. doi: 10.1111/all.13266. Epub 2017 Aug 30.
Borysowski J, Saxena A, Bateman-House A, Papaluca M, Różyńska J, Wnukiewicz-Kozłowska A, Górski A. Expanded access: growing importance to public health. J Epidemiol Community Health. 2018 Jul;72(7):557-558. doi: 10.1136/jech-2017-210409. Epub 2018 Apr 7.
Cerreta, F., Padrão, A., Skibicka-Stepien, I. et al. Medicines for older people. Assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal products Eur Geriatr Med (2018) 9: 415. https://doi.org/10.1007/s41999-018-0071-1
Cilia M, Ruiz S, Richardson P, Salmonson T, Serracino-Inglott A, Wirth F, Borg JJ. Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use. AAPS PharmSciTech. 2018 Feb;19(2):489-511
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Collignon O, Koenig F, Koch A, Hemmings RJ, Pétavy F, Saint-Raymond A, Papaluca-Amati M, Posch M. Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency. Trials. 2018 Nov 20;19(1):642. doi: 10.1186/s13063-018-3012-x.
Collignon O, Petavy F. Statistical considerations about the design and endpoints of randomised clinical trials for children with irritable bowel syndrome Neurogastroenterol Motil. 2018 May;30(5):
Day S, Jonker AH, Lau LPL, Hilgers RD, Irony I, Larsson K, Roes KC, Stallard N. Recommendations for the design of small population clinical trials Orphanet J Rare Dis. 2018 Nov 6;13(1):195. doi: 10.1186/s13023-018-0931-2.
Ecker A, Mariz S, Naumann-Winter F, Norga K, Barisic I, Girard T, Tomasi P, Mentzer D, Sepodes B. Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations. Arch Dis Child. 2018 May;103(5):427-430. doi: 10.1136/archdischild-2017-313352. Epub 2017 Oct 31.
Eichler HG, Barker R, Bedlington N, Bouvy JC, Broekmans AW, Bucsics A, Cerreta F, Corriol-Rohou S, Granados A, Le Cam Y, Schuurman A. The evolution of adaptiveness: balancing speed and evidence. Nat Rev Drug Discov. 2018 Dec;17(12):845-846. doi: 10.1038/nrd.2018.90. Epub 2018 Jul 6.
Eichler HG, Sweeney F. The evolution of clinical trials: Can we address the challenges of the future? Clin Trials. 2018 Feb;15(1_suppl):27-32.
Gerven J van, Bonelli M. Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. Br J Clin Pharmacol. 2018 Jul;84(7):1401-1409. doi: 10.1111/bcp.13550. Epub 2018 May 30.
Goedecke T, Morales D, Pacurariu A, Kurz X. Measuring the impact of medicines regulatory interventions – Systematic review and methodological considerations Br J Clin Pharmacol. 2018 Mar;84(3):419-433
Goedecke T, Morales D, Pacurariu A, Kurz X. Response to Comment on `Measuring the impact of medicines regulatory interventions – Systematic review and methodological considerations` Br J Clin Pharmacol. 2018 Sep;84(9):2169-2170. doi: 10.1111/bcp.13664. Epub 2018 Jul 3.
Hofer MP, Hedman H, Mavris M, Koenig F, Vetter T, Posch M, Vamvakas S, Regnstrom J, Aarum S. Marketing authorisation of orphan medicines in Europe from 2000 to 2013. Drug Discov Today. 2018 Feb;23(2):424-433
Hwang TJ, Tomasi PA, Saint-Raymond A, Bourgeois FT. Availability of paediatric information in European Medicines Agency approvals. Lancet Child Adolesc Health. 2018 May;2(5):e9. doi: 10.1016/S2352-4642(18)30101-9. Epub 2018 Apr 12.
Hwang TJ, Tomasi PA, Bourgeois FT. Delays in completion and results reporting of trials under the Paediatric Regulation in the European Union: cohort study PLoS Med. 2018 Mar 1;15(3)
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Ioannou F, Burnsteel C, Mackay DKJ, Gay CG. Regulatory pathways to enable the licencing of alternatives to antibiotics Biologicals. 2018 May;53:72-75. doi: 10.1016/j.biologicals.2018.03.003. Epub 2018 Mar 31.
Kälviäinen R, Straus S, Dogne JM, Bakchine S, Haas M. Reducing valproate use in women with epilepsy vaccine.2018.11.082
Kondo H, Saint-Raymond A, Yasuda N. What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016. Ther Innov Regul Sci. 2018 Mar;52(2):214-219. doi: 10.1177/2168479017720248. Epub 2017 Jul 21.
Kurz X, Perez ‐Gu tth a n n S, th e EN Ce PP Ste e r i n g G r o u p . Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):245-252
Mazzaglia G, Straus SMJ, Arlett P, da Silva D, Janssen H, Raine J, Alteri E. Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs. Drug Saf. 2018 Feb;41(2):191-202
McCarthy D, Bahri P, Barnes J, Delumeau JC, Edwards B, Harrison-Woolrych M. An Update on ISoP Special Interest Groups (SIGs) Drug Saf. 2018 Jan;41(1):1-6
Moellenhoff K, Dette H, Kotzagiorgis E, Volgushev S, Collignon O. Regulatory assessment of drug dissolution profiles comparability via maximum deviation Statistics in Medicine. 2018;1–14.
Morales DR, Slattery J, Evans S, Kurz X. Antidepressant use during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies and methodological considerations BMC Med. 2018 Jan 15;16(1):6.
Morales DR, Slattery J, Pinheiro L, Kurz X, Hedenmalm K. Indications for Systemic Fluoroquinolone Therapy in Europe and Prevalence of Primary Care Prescribing in France, Germany and the UK: Descriptive Population Based Study Clin Drug Investig. 2018 Oct;38(10):927-933. doi: 10.1007/s40261-018-0684-7.
Newbould V, Le Meur S, Goedecke T, Kurz X. Correction to: Medication Errors – a characterisation of spontaneously reported cases in EudraVigilance Drug Saf. 2018 Dec;41(12):1439-1440. doi: 10.1007/s40264-018-0700-0
Nordenmalm S, Tomasi P, Pallidis C. More medicines for children – impact of the EU Paediatric Regulation Arch Dis Child. 2018 Jun;103(6):557-564. doi: 10.1136/archdischild-2017-313309. Epub 2018 Feb 28.
O'Sullivan J, Ponzano S, Bonelli M. Safety Pharmacology Study Results and their Impact on the Design of First-in-human Trials for Authorised Oncology Therapies. Pharmaceutical Medicine, 32(5), 335-341, 2018
Pacurariu A, Plueschke K, McGettigan P, Morales DR, Slattery J, Vogl D, Goedecke T, Kurz X, Cave A. Electronic healthcare databases in Europe: characterisation and assessment of usefulness for benefit-risk evaluation of medicines BMJ Open 2018;8:e023090. doi: 10.1136/bmjopen-2018-023090
Pacurariu A, Plueschke K, Olmo CA, Kurz X. Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):823-826. doi: 10.1002/pds.4449. Epub 2018 May 11.
Pacurariu AC, Hoeve CE, Arlett P, Genov G, Slattery J, Sturkenboom MCJM, Straus SMJM. Is patient exposure pre and post-approval a determinant of the timing and frequency of occurrence of safety issues? Pharmacoepidemiol Drug Saf. 2018 Feb;27(2):168-173
Peschel W, Monedero Alvarez B Harmonised European standards as basis for the safe use of herbal medicinal products and their marketing authorisation in EU member states Pharmaceutical Medicine; August 2018, Volume 32, Issue 4, pp 275–293
Pinheiro LC, Candore G, Zaccaria C, Slattery J, Arlett P. An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance. Pharmacoepidemiol Drug Saf. 2018 Jan;27(1):38-45
Plueschke K, McGettigan P, Pacurariu A, Kurz X, Cave A. EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decision-making BMJ Open. 2018 Jun 14;8(6):e021864. doi: 10.1136/bmjopen-2018-021864.
Pomba C, Catry B, Edo JT, Jukes H. Licensing and Approval of Antimicrobial Agents for Use in Animals Microbiol Spectr. 2018 Aug;6(4). doi: 10.1128/microbiolspec.ARBA-0016-2017.
Ponzano S, Blake K, Bonelli M, Enzmann H; European Medicines Agency Committee for Human Medicinal Products “First-in-Human Guideline Drafting Group”. Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective. Clin Pharmacol Ther. 2018 Apr;103(4):564-566
Ponzano S, Nigrelli G, Fregonese L, Eichler I, Bertozzi F, Bandiera T, Galietta LJV, Papaluca M. A European regulatory perspective on cystic fibrosis: current treatments, trends in drug development and translational challenges for CFTR modulators. Eur Respir Rev. 2018 Apr 13;27(148). pii: 170124. doi: 10.1183/16000617.0124-2017. Print 2018 Jun 30.
Postigo R, Brosch S, Slattery J, van Haren A, Dogné JM, Kurz X, Candore G, Domergue F, Arlett P. EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection Drug Saf. 2018 Jul;41(7):665-675. doi: 10.1007/s40264-018-0647-1.
Postmus D, Richard S, Bere N, van Valkenhoef G, Galinsky J, Low E, Moulon I, Mavris M, Salmonsson T, Flores B, Hillege H, Pignatti F. Individual Trade-Offs Between Possible Benefits and Risks of Cancer Treatments: Results from a Stated Preference Study with Patients with Multiple Myeloma. Oncologist. 2018 Jan;23(1):44-51
Sharma RA, Fumi L, Audisio RA, Denys A, Wood BJ, Pignatti F. Commentary: How will interventional oncology navigate the "valleys of death" for new medical devices? Br J Radiol. 2018 Feb;91(1083):20170643
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Sheean ME, Stoyanova-Beninska V, Capovilla G, Duarte D, Hofer MP, Hoffmann M, Magrelli A, Mariz S, Tsigkos S, Shaili E, Polsinelli B, Ricciardi M, Bonelli M, Balabanov P, Larsson K, Sepodes B. Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions Drug Discov Today. 2018 Jan;23(1):26-48
Slattery J, Morales D, Pinheiro L, Kurz X. Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel Containing Intrauterine Devices in UK General Practice Drug Saf. 2018 Oct;41(10):951-958. doi: 10.1007/s40264-018-0683-x.
Slikker W Jr, de Souza Lima TA, Archella D, de Silva JB Junior, Barton-Maclaren T, Bo L, Buvinich D, Chaudhry Q, Chuan P, Deluyker H, Domselaar G, Freitas M, Hardy B, Eichler HG, Hugas M, Lee K, Liao CD, Loo LH, Okuda H, Orisakwe OE, Patri A, Sactitono C, Shi L, Silva P, Sistare F, Thakkar S, Tong W, Valdez ML, Whelan M, Zhao-Wong A. Emerging technologies for food and drug safety. Regul Toxicol Pharmacol. 2018 Oct;98:115-128. doi: 10.1016/j.yrtph.2018.07.013. Epub 2018 Jul 23.
Smith MY, Russell A, Bahri P, Mol PGM, Frise S, Freeman E, Morrato EH. The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products. Drug Saf. 2018 Apr;41(4):389-401. doi: 10.1007/s40264-017-0619-x.
Suarez-Sharp S, Cohen M, Kesisoglou F, Abend A, Marroum P, Delvadia P, Kotzagiorgis E, Li M, Nordmark A, Bandi N, Sjögren E, Babiskin A, Heimbach T, Kijima S, Mandula H, Raines K, Seo P, Zhang X. Applications of clinically relevant dissolution testing: workshop summary report AAPS J. 2018 Aug 27;20(6):93. doi: 10.1208/s12248-018-0252-3.
Sullivan JO, Blake K, Berntgen M, Salmonson T, Welink J; Pharmacokinetics Working Party. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines. Clin Pharmacol Ther. 2018 Sep;104(3):539-545. doi: 10.1002/cpt.957. Epub 2018 Jan 9.
Tacconelli E, Carrara E, Savoldi A, Harbarth S, Mendelson M, Monnet DL, Pulcini C, Kahlmeter G, Kluytmans J, Carmeli Y, Ouellette M, Outterson K, Patel J, Cavaleri M, Cox EM, Houchens CR, Grayson ML, Hansen P, Singh N, Theuretzbacher U, Magrini N; WHO Pathogens Priority List Working Group. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis. 2018 Mar;18(3):318-327
Tafuri G, Lucas I, Estevão S, Moseley J, d'Andon A, Bruehl H, Gajraj E, Garcia S, Hedberg N, Massari M, Molina A, Obach M, Osipenko L, Petavy F, Petschulies M, Pontes C, Russo P, Schiel A, Van de Casteele M, Zebedin-Brandl EM, Rasi G, Vamvakas S. The impact of parallel regulatory-health technology assessment scientific advice on clinicaldevelopment. Assessing the uptake of regulatory and health technology assessment recommendations. Br J Clin Pharmacol. 2018 May;84(5):1013-1019. doi: 10.1111/bcp.13524. Epub 2018 Mar 5.
Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Krauss A, Kwong YL, Little RF, Mahon FX, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Rule S, Sloan J, Sonneveld P, Thompson CA, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Wintrich S, Seymour JF, Habermann TM. Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies. Lancet Haematol. 2018 Nov;5(11):e563-e598. doi: 10.1016/S2352-3026(18)30051-6. Epub 2018 Jun 18.
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Tsigkos S, Hofer MP, Sheean ME, Mariz S, Larsson K, Naumann-Winter F, Fregonese L, Sepodes B. Establishing rarity in the context of orphan medicinal product designation in the European Union Drug Discov Today. 2018 Mar;23(3):681-686
Tzogani K, Penninga E, Schougaard Christiansen ML, Hovgaard D, Sarac SB, Camarero Jimenez J, Garcia I, Lafuente M, Sancho-López A, Salmonson T, Gisselbrecht C, Pignatti F. EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma. Oncologist. 2018 May;23(5):594-602. doi: 10.1634/theoncologist.2017-0328. Epub 2018 Jan 25.
Tzogani K, van Hennik P, Walsh I, De Graeff P, Folin A, Sjöberg J, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti F. The European Medicines Agency Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma. Oncologist. 2018 May;23(5):631-636. doi: 10.1634/theoncologist.2017-0301. Epub 2017 Nov 30. Erratum in: Oncologist. 2018 Jul;23(7):870.
Vannice KS, Wilder-Smith A, Barrett ADT, Carrijo K, Cavaleri M, de Silva A, Durbin AP, Endy T, Harris E, Innis BL, Katzelnick LC, Smith PG, Sun W, Thomas SJ, Hombach J. Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines. Vaccine. 2018 Jun 7;36(24):3411-3417. doi: 10.1016/j.vaccine.2018.02.062. Epub 2018 Mar 7.
Vatzaki E, Straus S, Dogne HM, Garcia Burgos J, Girard T, Martelletti P. Latest clinical recommendations on valproate use for migraine prophylaxis in women of childbearing age: overview from European Medicines Agency and European Headache Federation J Headache Pain. 2018 Aug 14;19(1):68. doi: 10.1186/s10194-018-0898-3.
